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Selective Estrogen Receptor Modulator

Tamoxifen for Breast Cancer Risk Reduction

Phase 2

Recruiting

Led By Seema A Khan

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women with HSV infection on suppressive antiviral therapy

Participants aged 18 to 55

Must not have

History of SERM use within the past 5 years with duration of use > 1 year

History of invasive breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6, 12, and 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a low dose of tamoxifen to see if it can reduce breast density in women who have a higher risk of breast cancer. Breast density is a known risk factor for breast cancer

Who is the study for?

This trial is for premenopausal women at higher than average risk for breast cancer, particularly those with dense breasts. The study aims to find the best dose of Tamoxifen that can reduce breast density and thus lower the risk of developing breast cancer.

What is being tested?

The RENAISSANCE Trial is testing low-dose Tamoxifen's effectiveness in reducing breast density among high-risk women. It includes assessments like questionnaires, biopsies, biospecimen collection, and mammography to monitor changes and responses.

What are the potential side effects?

Tamoxifen may cause side effects such as hot flashes, vaginal dryness or discharge, menstrual irregularities, fatigue, mood swings, and a slight increase in the risk of blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman taking medication to control my HSV infection.

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I am between 18 and 55 years old.

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I can take care of myself but might not be able to do active work.

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I am a premenopausal woman according to age and hormone levels.

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I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.

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I am a woman with controlled hepatitis B.

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I use hormonal contraceptives and will not change them during the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have used SERMs for more than a year in the last 5 years.

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I have had invasive breast cancer before.

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I have a history of uterine cancer or abnormal cell growth in my uterus, and my uterus has not been removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6, 12, and 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6, 12, and 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6, 12, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of women who have a response at any time point

Secondary study objectives

Adherence to final tamoxifen dose

Baseline dense area

Longitudinal change in serum biomarkers of tamoxifen response

+2 more

Other study objectives

Breast tissue-based biomarkers

Change in breast cancer risk estimates

Single nucleotide polymorphisms (SNPs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prevention (tamoxifen)Experimental Treatment5 Interventions

Participants receive tamoxifen 5mg PO QD for 6 months. Participants with aDAR \>= 10% on mammogram at 6 months continue receiving tamoxifen 5mg PO QD for 12 months. Participants with aDAR \< 10% at 6 months are escalated to receive tamoxifen 10mg PO QD for 6 months. Participants with aDAR \>= 10% after 6 months of tamoxifen 10mg continue receiving tamoxifen 10 mg PO QD for 6 months. Participants with aDAR \< 10% after 6 months of tamoxifen 10mg are given the option of continuing tamoxifen 10mg or escalating to receive tamoxifen 20mg PO QD for 6 months. Participants undergo mammography and collection of blood samples at screening and on study. Participants may optionally undergo biopsy at screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

Tamoxifen

2005

Completed Phase 4

~30110